The European Union (EU) establishes rules for the prevention, control and eradication of transmissible spongiform encephalopathies. Its aim is to prevent a new food crisis like those in the '90s and to ensure a high level of public health and food safety.

ACT

Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies [See amending act(s)].

SUMMARY

Since the early ’80s, the appearance of several transmissible spongiform encephalopathies (TSEs) has been ascertained separately in man (Creutzfeldt-Jakob Disease and its variants) and in animals (bovine spongiform encephalopathy or BSE).

SCOPE

This Regulation lays down rules for the prevention, control and eradication of transmissible spongiform encephalopathies in animals. It applies to the production, placing on the market and in certain cases the exportation of live animals and products of animal origin.

This Regulation does not apply to:

cosmetic products, medicaments, raw materials or any other product of animal origin used in their production;

raw materials or any other product of animal origin not used in the production of human food, animal feed or fertilisers;

products of animal origin intended for exhibitions, teaching, scientific research, special studies or analyses, provided those products are not consumed finally or reused by humans or by animals;

live animals used in or intended for research.

DETERMINATION OF BSE STATUS

The Commission establishes a list which ranks the Member States, the third countries or their regions in different categories according to the BSE risk. The European system for the classification of countries according to their level of risk is similar to that recommended by the World Organisation for Animal Health (OIE).

There are three levels for classifying the BSE status of a country or one of its regions:

level 1: countries or regions with a negligible BSE risk;

level 2: countries or regions with a controlled BSE risk;

level 3: countries or regions with undetermined BSE risk.

PREVENTION OF TSEs

Monitoring system

Each Member State must carry out an annual programme for monitoring BSE and scrapie, which includes a screening programme using rapid tests. Annex III gives details of the monitoring system to be put in place for these two diseases. Besides the compulsory controls for all animals which show signs giving rise to a suspicion of TSE, rapid post mortem screening must also be performed on a large number of animals (primarily bovine, ovine and caprine animals), including (but not limited to) when they are intended for human consumption.

At the latest by 31 March each year, Member States must submit to the Commission an annual report containing information on the number of suspected cases per animal species placed under movement restrictions. Within three months following receipt of the report, the Commission has to present a consolidated report on the epidemiological situation in the Union.

The Member States must also inform the Commission and the other Member States of the occurrence in their territory of other cases of TSEs.

Annex III, like the other annexes of the Regulation, was amended in 2013 to reflect new scientific advice on TSEs and attempt to clarify an excessively complex procedure.

Prohibitions concerning animal feeding

The Regulation prohibits the feeding to ruminants of animal protein and animal feed containing such protein. As regards the feeding of farm animals with the exception of carnivorous fur-producing animals, it is forbidden to use processed animal protein, gelatine of ruminant origin, blood products, hydrolysed protein, dicalcium and tricalcium phosphates of animal origin.

Annex IV of the Regulation, as amended in 2013, specifies the conditions under which certain animal proteins can nevertheless be used in the feeding of non-ruminants, ruminants and fish. Since 1 November 2003, the Member States have had to provide the other Member States and the Commission with an up-to-date list of EU-approved slaughterhouses which do not slaughter ruminants. They must also send a list of the establishments authorised to produce the animal feeding stuffs and animal proteins specified above.

The export to a third country of processed animal proteins of ruminant origin and of products containing such proteins must comply with the legislation in force within the European Union. In advance and in writing, the third country of destination must undertake to use and/or re-export the products taking due account of their intended final use. The Member State authorising the export must inform the other Member States and the Commission.

Specified risk material

Member States with a negligible BSE risk shall continue to be subject to the obligation to remove specific risk material (SRMs).

For countries or regions with a controlled or undetermined BSE risk, the bones of bovine, ovine and caprine animals may not be used to produce mechanically separated meat. The head meat and vertebral column of bovine animals over 30 months of age and the tongues of bovine animals of all ages must be harvested using specific methods.

Specified risk material must be removed in slaughterhouses, in cutting plants in the case of the vertebral column of bovine animals, and where appropriate in the approved establishments referred to in Regulation (EC) No 1069/2009 on animal by-products not intended for human consumption. On removal, all SRMs or by-products must be stained with a dye or marked with a marker. They must be used and destroyed in accordance with Regulation (EC) No 1069/2009. Member States must carry out frequent official inspections to verify the application of these rules and to ensure that measures are taken to avoid contamination at all levels.

Training programmes

Member States must ensure that staff of the competent authority, of diagnostic laboratories and colleges of agriculture and veterinary medicine, as well as official veterinarians, slaughterhouse personnel and animal breeders, have been given training in the clinical signs and epidemiology of TSE. To this end, the Community may grant financial assistance.

CONTROL AND ERADICATION OF TSEs

Measures with respect to animals suspected of being infected by a TSE

Without prejudice to European measures concerning the notification of diseases, the Member States must ensure that any animal suspected of being infected by a TSE is notified to the competent authorities. They must regularly inform each other and the Commission of the cases notified.

Any animal suspected of being infected by a TSE must be placed under an official movement restriction until the results of a clinical and epidemiological examination are known, or must be killed for laboratory examination under official control. All other ruminants on the holding are also subject to an official movement restriction until the results are available.

If it appears that a suspect animal may have been exposed to the TSE on a holding other than the one where the suspicion occurred, the competent authority may decide that only the suspect animal shall be placed under an official movement restriction and may also place other holdings under surveillance.

Measures in cases where a TSE has been confirmed

When a case of TSE has been officially confirmed, the following measures must be applied:

an inquiry must be launched to identify the possible origin of the disease and all animals and derived products which may be contaminated;

in case of confirmation of BSE in a bovine animal, killing and complete destruction of the bovine animals identified as being at risk by the inquiry (in particular, animals belonging to the birth or feed cohort of the infected animal).

in case of confirmation of BSE in an ovine or caprine animal, killing and complete destruction of all ovine and caprine animals in the herd;

in case of confirmation of TSE in an ovine or caprine animal, BSE being excluded, killing and complete destruction of all ovine and caprine animals in the herd or, and solely in the case of ovine animals, killing and selective destruction of animals with a genotype susceptible to TSEs. If the infected animal has been introduced from another holding, the Member State may decide to apply eradication measures on the holding of origin in addition to, or instead of, the holding where the infection was confirmed.

Pending the results of the inquiry, the holding in which the infection was confirmed is placed under official control and any movement of animals susceptible to TSEs (and products of animal origin) from or to the holding must be strictly authorised by the competent authority. This measure guarantees the identification and effective traceability of movements of animals (or derived products). If it is discovered that the holding on which the TSE was confirmed is not that where the animal was exposed to the agent responsible for the TSE, the authorities may place several holdings under control in addition to the holding on which the animal was exposed.

Derogations from these general rules may however be granted and their scope has changed over time to reflect new scientific studies on TSEs.

Owners are compensated without delay for the loss of animals or products of animal origin.

Member States must draw up guidelines specifying the national measures to be implemented, as well as competences and responsibilities where cases of TSE are confirmed.

PLACING ON THE MARKET, IMPORTATION AND EXPORTATION

Live animals, their semen, embryos and ova

When their importation, placing on the market or exportation is authorised, live animals and their embryo and ova must be accompanied by appropriate animal health certificates. In the case of ovine and caprine animals, the certificates must attest that the animals come from holdings in which no case of scrapie has ever been diagnosed or, in the case of ovine animals, that they are of a genotype resistant to TSEs.

It is prohibited to place on the market the last-born progeny to which female bovine, ovine or caprine animals infected with a TSE gave birth during the years preceding the appearance of the first clinical signs of the disease.

Placing on the market and importation of products of animal origin

This Regulation imposes a high level of safety as regards BSE. It requires the application to imports of bovine meat into the European Union of the same measures as those applicable within the Union, with the exception of third countries with a negligible BSE risk. For example, it prohibits imports from third countries with a controlled BSE risk of specified risk material or meat-based products containing SRM. Hence the third countries concerned must ensure that the animal slaughtering techniques comply with the European rules.

These rules also apply to a list of bovine, ovine and caprine products from third countries.

Safeguard measures

The Regulation provides for safeguard measures which may be applied to intra-European trade and trade with third countries. These measures are basically derived from existing Directives in this field (notably Directives 89/662/EEC,90/425/EEC, 91/496/EEC and 97/78/EC). For example, if an importing Member State ascertains, during official controls, the presence of a disease which presents a serious threat to human or animal health, the authorities may take more restrictive measures, including the quarantining of the animals concerned. The Commission may also adopt such measures.

Reference laboratories, sampling, testing and controls

To ensure the uniformity of scientific analysis and reliable results, national and European reference laboratories must be designated. If necessary, experts from the Commission may check the functioning of their installations.

The national reference laboratories are mainly responsible for verifying the diagnostic methods used in the regional laboratories and their coordination within the Member State. They are required to cooperate with the Community reference laboratory.

A Member State without a national reference laboratory must be entitled to use a European reference laboratory or that of another Member State.

Together with the Commission, the European reference laboratory has to coordinate the methods employed in the Member States for diagnosing BSE and contributes to identifying outbreaks of TSE.

The analysis and sampling methods used must comply with the standards laid down in the Manual of the World Organisation for Animal Health (OIE). Inter alia they must set out procedures to be used in the event of suspect cases and in the framework of the annual monitoring programme.

Institutional provisions

The Commission is assisted by the Standing Committee on the Food Chain and Animal Health and by the appropriate scientific committees on measures which could have an impact on public health.

By 1 July 2003 at the latest, each Member State must complete a survey of the prion protein genotype of each of its sheep breeds which are native or form a significant population in its territory. It must provide a report to the Commission by 1 October 2003 at the latest.

Communication from the Commission of 15 July 2005: “TSE Road map” [ COM(2005) 322 – Not published in the Official Journal].

Commission Decision 2007/453/EC of 29 June 2007 establishing the BSE status of Member States or third countries or regions thereof according to their BSE risk [Official Journal L 172 of 30.6.2007].

Communication from the Commission of 16 July 2010: “The TSE Roadmap 2 A Strategy paper on Transmissible Spongiform Encephalopathies for 2010-2015” [ COM(2010) 384 final – Not published in the Official Journal].

The majority of short and medium term actions envisaged in the first TSE Roadmap have been achieved and the positive trend already observed in 2005 in the Bovine Spongiform Encephalopathy (BSE) epidemic has continued since then. The goal for the coming years is to continue the review of the measures, while assuring a high level of food safety. Amendments to the TSE rules are and will continue to be taken following a stepwise approach supported by a solid scientific basis. The EU is on the point of eradicating BSE within its cattle population; however, it should continue to monitor the situation in case of a potential re-emergence of BSE or emergence of a new TSE agent in the cattle population. The review should be based primarily on scientific advice and technical issues related to the control and enforcement of the new measures.